BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 24GAX0.75IN PRN SLM

    MDR report key: 9898744 · Received March 30, 2020

    Report

    Report Number
    3006948883-2020-00103
    Event Type
    Malfunction
    Date Received
    March 30, 2020
    Date of Event
    February 21, 2020
    Report Date
    April 6, 2020
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9023847. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. UNFORTUNATELY, A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTIMA-II 24GAX0.75IN PRN SLM EXPERIENCED CATHETER DAMAGED/DEFECTIVE. THE PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DUE TO THE PATIENT'S CONDITION, THE PATIENT NEEDED ENHANCED MAGNETIC RESONANCE, AND WAS GIVEN CLOSED VEIN INDWELLING NEEDLE PUNCTURE IN ACCORDANCE WITH THE DOCTOR'S ADVICE, WHICH WAS USED TO PUSH THE INJECTION TO CHECK THE DRUG SOLUTION. AFTER OPENING A CLOSED INDWELLING NEEDLE, THE NURSING STAFF TIMELY FOUND THAT THERE WAS DAMAGE AT THE CATHETER, AND TIMELY REPLACED IT, SO AS TO AVOID THE PAIN CAUSED BY REPEATED PUNCTURING AND PROTECT THE PATIENT'S BLOOD VESSELS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTIMA-II 24GAX0.75IN PRN SLM EXPERIENCED CATHETER DAMAGED/DEFECTIVE. THE PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DUE TO THE PATIENT'S CONDITION, THE PATIENT NEEDED ENHANCED MAGNETIC RESONANCE, AND WAS GIVEN CLOSED VEIN INDWELLING NEEDLE PUNCTURE IN ACCORDANCE WITH THE DOCTOR'S ADVICE, WHICH WAS USED TO PUSH THE INJECTION TO CHECK THE DRUG SOLUTION. AFTER OPENING A CLOSED INDWELLING NEEDLE, THE NURSING STAFF TIMELY FOUND THAT THERE WAS DAMAGE AT THE CATHETER, AND TIMELY REPLACED IT, SO AS TO AVOID THE PAIN CAUSED BY REPEATED PUNCTURING AND PROTECT THE PATIENT'S BLOOD VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365222 INTIMA-II 24GAX0.75IN PRN SLM INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9023847

    Patients

    Seq Age Sex Outcome Treatment
    1 Other